SAPIEN M3 System for Mitral Regurgitation
(SAPIEN M3 EFS Trial)
Trial Summary
What is the purpose of this trial?
This trial will test the safety and effectiveness of the SAPIEN M3 System in patients with severe mitral regurgitation. The device is designed to help the heart valve close properly, preventing blood from flowing backward. The study aims to gather information for future research on this treatment. The SAPIEN M3 System is part of the SAPIEN family of heart valves, which have been used in various applications including aortic and mitral valve replacements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be stable on heart failure medication for at least 2 weeks before the procedure.
What data supports the effectiveness of the SAPIEN M3 System treatment for Mitral Regurgitation?
The Edwards Sapien 3 valve, a component of the SAPIEN M3 System, has been optimized to reduce complications in aortic valve treatments, suggesting potential effectiveness in similar heart valve conditions. Additionally, the PASCAL system, another Edwards Lifesciences device for mitral regurgitation, has shown positive outcomes in reducing mitral valve issues, indicating that similar technologies from the same company may be effective.12345
Is the SAPIEN M3 System generally safe for humans?
The Edwards SAPIEN transcatheter heart valve, a related device, has been evaluated for safety in high-risk patients with aortic stenosis and was found to have benefits that outweigh the risks, according to an FDA panel. Additionally, early trials for similar devices in different heart conditions have been conducted to assess safety.16789
How is the SAPIEN M3 System treatment for mitral regurgitation different from other treatments?
The SAPIEN M3 System is unique because it uses a transcatheter approach, meaning it is delivered through a small tube inserted into a blood vessel, which is less invasive than traditional surgery. This system is adapted from the SAPIEN 3 valve, which is known for its precise implantation and reduced risk of leakage around the valve, making it a novel option for treating mitral regurgitation.1231011
Eligibility Criteria
This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects will undergo transcatheter mitral valve replacement using the SAPIEN M3 System
Follow-up
Participants are monitored for safety and effectiveness after treatment, including reduction in mitral regurgitation
Treatment Details
Interventions
- Edwards SAPIEN M3 System
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Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD